510(k) Report

510(k) · Cleared

Cleared

Roei Working Element and Roel Cutting Loops

K050910510(k) TraditionalCleared Jun 16, 200566-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roei Medical Technologies, Ltd. · FAS Electrode, Electrosurgical, Active, Urological

Cleared on Jun 16, 2005 as substantially equivalent to K954050 (KARL STORZ Endoscopy-America, Inc., 1995) and 7 other predicates after a 66-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.

Decided
Jun 16, 2005
Review
66 days
Class
Class II
Product code
FAS
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K903323 (1990). 13 ancestors in all, the oldest K790071 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestors1995: 2 other ancestors1992: 1 other ancestor1990: 1 other ancestor1979: 1 other ancestor2006: 1 descendant clearedK903323 · Resectoscope Loops · Olympus Corp. · 1990K971512 · Ams Coaguloop Resection Electrode · American Medical Systems, Inc. · 1997K991314 · Coaguloop · American Medical Systems, Inc. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 4 other ancestors 1 generation forward: 1 descendant K991314 · Coaguloop · American Medical Systems, Inc. · 1999K971512 · Ams Coaguloop Resection Electrode · American Medical Systems, Inc. · 1997K903323 · Resectoscope Loops · Olympus Corp. · 19900
  1. Root · 3 generations backK903323 Resectoscope LoopsOlympus Corp. · 1990
  2. 2 generations backK971512 Ams Coaguloop Resection ElectrodeAmerican Medical Systems, Inc. · 1997
  3. 1 generation backK991314 CoaguloopAmerican Medical Systems, Inc. · 1999
  4. This deviceK050910 Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005
  5. Descendant · cites it directly · 0 of its ownK053322 Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K903323Resectoscope LoopsOlympus Corp.1990—
−2K971512Ams Coaguloop Resection ElectrodeAmerican Medical Systems, Inc.1997—
−1K991314CoaguloopAmerican Medical Systems, Inc.1999—
0 (this device)K050910Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd.2005—
+1K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199010
199210
199520
199620
199820
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K050910, 1990–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FAS device

  1. #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K954050Resectoscopes
Summary page 2
…and accessories Predicate Devices * Karl Storz Endoscopy - America, Inc.'s Resectoscopes Working Element and Cutting Loop Components (K954050) * Richard Wolf Medical Instruments Corporation's Resectoscope E-Line series Working Element and Cutting Loop C…
KARL STORZ Endoscopy-America, Inc.1995—
*K980302Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes
Summary page 2
…ting Loop Components (K954050) * Richard Wolf Medical Instruments Corporation's Resectoscope E-Line series Working Element and Cutting Loop Components (K980302) · ACMI's Resectoscope Working Elements and Cutting Loop Components (preamendment and K951972) * Olympu…
Richard Wolf Medical Instruments Corp.19981
*K951972Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths
Summary page 2
…es Working Element and Cutting Loop Components (K980302) · ACMI's Resectoscope Working Elements and Cutting Loop Components (preamendment and K951972) * Olympus Winter & IBE's Olympus Working Element (K992141) * American Medical Systems, Inc.'s AMS Coaguloop Rese…
Cabot Medical Corp.1995—
*K992141Olympus Working Element for Probes
Summary page 2
…· ACMI's Resectoscope Working Elements and Cutting Loop Components (preamendment and K951972) * Olympus Winter & IBE's Olympus Working Element (K992141) * American Medical Systems, Inc.'s AMS Coaguloop Resection Electrodes (1K991314 and K971512) * ACMI's…
Olympus Winter & Ibe GmbH1999—
*K991314Coaguloop
Summary page 2
…and K951972) * Olympus Winter & IBE's Olympus Working Element (K992141) * American Medical Systems, Inc.'s AMS Coaguloop Resection Electrodes (1K991314 and K971512) * ACMI's VaporTrode Tm and VaporTome Tm Resection Electrodes (K973820) * Karl Storz's KSEA Vaporizat…
American Medical Systems, Inc.1999—
*K971512Ams Coaguloop Resection Electrode
Summary page 2
…* Olympus Winter & IBE's Olympus Working Element (K992141) * American Medical Systems, Inc.'s AMS Coaguloop Resection Electrodes (1K991314 and K971512) * ACMI's VaporTrode Tm and VaporTome Tm Resection Electrodes (K973820) * Karl Storz's KSEA Vaporization Electrod…
American Medical Systems, Inc.1997—
*K973820Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode
Summary page 2
…merican Medical Systems, Inc.'s AMS Coaguloop Resection Electrodes (1K991314 and K971512) * ACMI's VaporTrode Tm and VaporTome Tm Resection Electrodes (K973820) * Karl Storz's KSEA Vaporization Electrodes (K961706) Intended Use ! Indications for Use The Roei Workin…
Circon Corp.1998—
*K961706P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator
Summary page 2
…odes (1K991314 and K971512) * ACMI's VaporTrode Tm and VaporTome Tm Resection Electrodes (K973820) * Karl Storz's KSEA Vaporization Electrodes (K961706) Intended Use ! Indications for Use The Roei Working Element and Roei Cutting Loops are endoscopic electrosurgica…
Fresenius USA, Inc.19961

Also cleared against K954050: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd.20060

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
  • 4 of the 13 ancestors have a recall of any class.
  • Of its descendants, K053322 (Roei Medical Technologies, Ltd., 2006) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K954050.

How does its category compare?

All FAS devices

FAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAS

2in 2025

2010: 32011: 12012: 22015: 12016: 12017: 22021: 22022: 12024: 12025: 2
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAS

150in 2010

2010: 150 days median
2007high 150 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FAS

1in 2023

2016: 22021: 42023: 1
2007high 4 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FAS

395in 2025

2007: 62008: 132009: 92010: 252011: 332012: 302013: 482014: 522015: 822016: 692017: 1212018: 702019: 612020: 1002021: 1022022: 1472023: 3292024: 3102025: 395
2007high 395 (2025) · low 6 (2007)2025

MAUDE reports naming product code FAS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—06
20080—013
20090—09
20103150025
20111—033
20122—030
20130—048
20140—052
20151—082
20161—269
20172—0121
20180—070
20190—061
20200—0100
20212—4102
20221—0147
20230—1329
20241—0310
20252—0395
20260—0—

What is it indicated for?

The Roei Working Element and Roei Cutting Loops are endoscopic electrosurgical accessories intended for use with monopolar resectoscope systems for the resection of soft tissue in transuretheral bladder tumor resection (TURBT), transurethral prostatic and bladder biopsy, and transurethral resection of the prostate (TURP) procedures.

Indications for use as stated in the FDA summary.

Also cleared against K954050

2 other devices cite the same predicate.

  • K102663Aed ResectoscopeNational Advanced Endoscopy Devices, Inc. · 2010
  • K991563Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation…Henke Sass Wolf of America, Inc. · 1999

More from Roei Medical Technologies, Ltd.

2 FDA decisions under this applicant name. See the company

  • K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006

Recent decisions in FAS

The FAS category page

  • K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use…Dornier Medtech America Inc (Dmta) · 2025
  • K250522Multi4 SystemMulti4 Medical AB · 2025
  • K240504PLASMA EDGE SystemLamidey Noury Medical · 2024
  • K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation · 2022
  • K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 20211 recall

https://510kreport.com/device/K050910 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050910: Roei Working Element and Roel Cutting Loops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050910

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026